EP1328194B1 - Apparatus for cpap using a neural network - Google Patents

Apparatus for cpap using a neural network Download PDF

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EP1328194B1
EP1328194B1 EP01970474A EP01970474A EP1328194B1 EP 1328194 B1 EP1328194 B1 EP 1328194B1 EP 01970474 A EP01970474 A EP 01970474A EP 01970474 A EP01970474 A EP 01970474A EP 1328194 B1 EP1328194 B1 EP 1328194B1
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ann
breathing
map
cpap
sleep
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French (fr)
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EP1328194A1 (en
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Ove Eklund
Petter Knagenhjelm
Jan Hedner
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Breas Medical AB
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Breas Medical AB
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/087—Measuring breath flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7264—Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems
    • A61B5/7267—Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems involving training the classification device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A61M16/024—Control means therefor including calculation means, e.g. using a processor
    • A61M16/026—Control means therefor including calculation means, e.g. using a processor specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
    • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • A61M2016/0021—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with a proportional output signal, e.g. from a thermistor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/08—Other bio-electrical signals
    • A61M2230/10—Electroencephalographic signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/18—Rapid eye-movements [REM]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/205—Blood composition characteristics partial oxygen pressure (P-O2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/60—Muscle strain, i.e. measured on the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/62—Posture
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/70—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients

Definitions

  • the present invention relates to an apparatus for the detection and treatment of disordered breathing during sleep, in particular to an apparatus employing an artificial neural network map.
  • U. S. Patent No. 5,953,713 discloses a method for treating sleep disordered breathing comprising measuring a respiration-related variable at an interface placed over a patient's airway coupled to a pressurized gas, feeding frequency data obtained from the respiration related variable (s) into an artificial neural network trained to recognize patterns characterizing sleep disordered breathing; supplying pressurized gas to the patients airway in response to recognition of the artificial neural network of sleep disordered breathing.
  • the sampling frequency of the pressure transducer's output disclosed in the preferred embodiment is 512 Hz.
  • a Fourier transform is calculated everyl/16 second using a 32 sample values window.
  • Another aspect of frequency analysis is that, on the one hand, the precision is proportional to the number of input data but that, on the other hand, the response time is correspondingly increased. While high precision is welcome since rather small changes in breath pattern can be detected, a slower response increases the risk of progressive deterioration of the airway aperture, and thereby more severe respiratory disturbance before the patient is aroused. Other methods of detecting sleep disorder are based on breath-by-breath analysis
  • ACPAP automatic continuous positive airways pressure apparatus
  • the present invention is based on the insight that a direct analysis of the flow signal is more specific than an analysis of disordered breath, in particular flow limited breath, based on frequency analysis.
  • an automatic continuous positive airways pressure apparatus in which the air flow from a CPAP or other system providing positive air pressure to a patient is measured for calculation of a number of parameters specific to the signal.
  • the set of parameters comprises cepstrum coefficients and energy content, and is selected to indicate an apneic event of breathing during sleep, such as apnea, hypoapnea, and flow limitation.
  • Data for these parameters collected from a large number of patients were used to train an artificial neural network to teach the system the variation ranges of the parameters for subsets of patients under a number of circumstances.
  • the result from the artificial neural network is obtained as a low-dimensional grid of nodes in which each respiration type is represented by trajectory or a subsets of nodes. A trajectory for a normal breath looks very different from that of a breath during disturbed sleep.
  • CPAP pressure is increased. In contrast, CPAP pressure is reduced in a normal condition.
  • an apparatus for the detection and treatment of disordered breathing during sleep for use with a CPAP including a probe for sampling breathing air flow rate data, in particular on inhalation, and an artificial neural network map for analyzing, directly or indirectly, said data to control breathing air pressure.
  • the apparatus according to the present invention is arranged to:
  • the artificial neural network is trained with data collected from a large number of patients.
  • the data will have been collected from patients differing in many aspects: sex, age, body weight, breath pattern, etc.
  • variants of sleep disordered breathing such as those occurring preferentially in the back position, those occurring during particular stages of sleep, and those occurring under the influence of drugs or alcohol need to be addressed.
  • Such data are advantageously collected in sleep laboratories in which the state of sleep is followed as well as the type and severity of the breathing disturbance is monitored by use of a polysomnography system.
  • the collected data form a primary database.
  • the data is quantified under formation of a small secondary dedicated database which can be stored in a ACPAP.
  • a dedicated secondary database obtained from a primary database comprising data collected from a large number of persons is stored in the ACPAP.
  • the ANN comprises a number of nodes representing sets of training data. Each note reflects a state or an incident (feature). Neighboring nodes represent incidents of small geometric distance. In the same way as in training an incident vector is extracted for each flow data sample. The Euclidean distance from the incident vector to each node is calculated. The node in closest proximity to the vector is associated with it. Sequences of incident vectors are followed as sequences of nodes in the artificial neural network. It can be said that a sequence of nodes is the response of the network. Thus a trajectory in the geometric structure of the network (response) is followed rather than in the parameter space. The fact that the dimension of the network most often is smaller than the parameter space is of advantage since calculation thereby is simplified. The response from the network forms the basis for distinguishing between apnea, hypoapnea and a normal breathing state and thus, for CPAP pressure control.
  • the invention thus is based on the use of an artificial neural network (ANN) of Kohonen-map type (associative memory; T. Kohonen, Self-Organization and Associative Memory, 2 nd Ed., Springer Verl., Berlin 1987) for detecting apnea or apnea-like episodes.
  • ANN artificial neural network
  • the ANN is trained with data obtained from a number of patients in a sleep laboratory.
  • the readily trained ANN forms a global (universal) structure of data stored in a non-volatile memory in an ACPAP.
  • traces trajectories
  • a normal breathing cycle forms a closed trajectory.
  • a trajectory deviating from normal is indicative of a breath disturbance.
  • the ANN is structured in way so as to make certain areas represent initial stages of apnea.
  • the passage of a trajectory through such an area or touching its border indicates that the amount of air provided to the patient should be increased so as to re-establish normal breathing.
  • Once breathing has been normalized the adduced amount of air is reduced to normal, i.e., to the preestablished base value.
  • the artificial neural network is trained in two phases described in P. Brauer and P. Knagenhjelm, Infrastructure in Kohonen Maps, Proc. IEEE ICASSP, Glasgow 1989.
  • the purpose of the analysis is to extract, from the series of air flow rate measurements, values of the parameters chosen to classify and detect apneic and hypoapneic states.
  • the parameters are made to form an incident or feature vector on which all training and decision-making is based. All sample values are individually analyzed in preparation for a quick response to changes in flow which are typical forewarnings of an apneic or hypoapneic state.
  • linear predictive coding is used to analyze the parameter values fed to the neural network.
  • a linear predictive coding analysis comprising four parameters is carried out for all samples.
  • the so-called A-parameters from the analysis are converted to cepstrum parameters for optimal correlation between parameter distance and conceptual distance, that is, so-called associativity.
  • the prediction error in calculating linear predictive coding is used as a basis for the parameter next in line.
  • the error is filtered to counteract short-term variations and normalized with the total energy of the analytical window.
  • a larger window than for the linear predictive coding analysis is used.
  • the energy of the latest windows can be used to calculate a line the inclination which describes a trend.
  • the difference in trend is used as a further parameter.
  • the inclination of a trend line calculated from measurements and is used as a parameter.
  • PRIMARY DATA ANALYSIS The purpose of the analysis is to extract, from the series of air flow rate measurements, values of the parameters chosen to classify and detect apneic and hypoapneic states. In each single analysis the parameters are made to form an incident or feature vector on which all training and decision-making is based. All sample values are individually analyzed in preparation for a quick response to changes in flow which are typical forewarnings of an apneic or hypoapneic state.
  • Incident vector parameters LPC-Cepstrum.
  • LPC Linear Predictive Coding
  • A-parameters from the analysis are converted to cepstrum parameters for optimal correlation between parameter distance and conceptual distance, that is, associativity.
  • cepstrum introduced by Bogert et al. in connection with echo time series analysis designates the inverse Fourier transform of the logarithm of the power spectrum of a signal. The transformation of a signal into its cepstrum is a homo-morphic transformation, see A.V. Oppenheim and R.W. Schafer, Discrete-Time Signal Processing, Prentice Hall, Englewood Cliffs, NJ, 1989. Residual.
  • the error of prediction in calculating LPC is used as a basis for the following parameter.
  • the error is filtered to oppose short-term variations, and is normalized with the total energy for the analytical window.
  • Energy slope For calculations of energy larger windows are used than for LPC analysis. The energy at the most recent windows is used to calculate a line the slope of which describes a trend. Difference in trend. The difference in trend is used as a further parameter.
  • PARAMETERS To detect an apneic event (i.e. central/obstructive apnea, hypoapnea, and flow limitations) a model is used to characterize typical qualities and features of the flow-signal during the event.
  • the parameters of the model is chosen with the aim to be as distinct, unambiguous, and informative as possible.
  • the set of parameters shall respond to typical apneic events that are readily detected by physicians.
  • the values of the parameters are compiled to form a vector, below named the Feature Vector.
  • the values of the Feature Vector are extracted. This means that if the flow signal is measured f s times per second, and N parameter values are needed in the model, the data rate is increased from f s to N ⁇ f s samples per second.
  • the flow signal Prior to the extraction of parameter values, the flow signal is differentiated (high-pass filtered) to avoid the influence of the mean signal value.
  • the mean will vary with patients and/or hardware and do not contribute in the classification of apneic events, and is therefore removed.
  • Each N- dimensional Feature Vector can be regarded as one point in a N- dimensional signal space.
  • An Artificial Neural Network is iteratively trained to organize groups or clusters of Feature Vectors with similar properties.
  • the self organizing process known as Kohonen's Self-Organizing Feature Map [1-2] has shown great capability of performing this task.
  • the number of clusters is defined prior to the training and is determined by the required resolution of the ANN.
  • the training is initiated by a set of M clusters, randomly positioned in the N-dimensional signal space.
  • the database used for training is formed by compiling the Feature Vectors from a large number of patients with various sleep disorders and at all stages of sleep. During the training, each input Feature Vector is compared to each cluster to find the one with best resemblance to the input vector.
  • This cluster is voted winner, and is adjusted towards the input vector.
  • all other clusters within a neighborhood to the winner in another domain the so-called map-space are adjusted towards the input vector.
  • the map-space is usually of low dimension containing one node for each cluster in the signal-space.
  • the nodes are arranged in hexagonal or a square lattice, and the Euclidian distance between them defines their internal relation.
  • a node's neighborhood is usually defined by a neighborhood function and contains the set all nodes in the beginning of the training whereas only a few (or none) are considered neighbors at the end. The further away a node is to the winner in the map-space, the less the corresponding cluster in the signal-space is adjusted towards the input vector.
  • all adjustments are done in the signal space, while the rules of adjustments are defined in the map-space.
  • the training time is predetermined, and an annealing function is used to "freeze” down the system causing only small adjustments at the end of the training.
  • the neighborhood function creates correlation between the signal-space distance and the map-space distance allowing classification to be performed in the (low dimensional) map-space, rather than in the more complicated signal-space.
  • the method described above is known as "unsupervised learning", i.e. there is no need to use classified data in the training procedure described above. Classification of data into various apneic events is a tedious task.
  • the clusters will represent M features of the input flow signal including normal breathing, hypoapnea, flow-limitations, and apnea (provided these features are represented in the database used for training).
  • the response of the ANN is proportional to the signal distance between the input signal and all the clusters. See figure 2. Often this output is of less interest in the case of classification. The output is instead used to find the node with best resemblance to a classified input, such as normal breathing and apneic events. This is known as the labeling phase in the design of the ANN. Classified Feature Vectors are presented for the ANN, the output is observed, and the node giving the highest output is labeled with the presented feature. The actual output thereafter is the label rather than the response value.
  • the set of clusters are now stored in the memory of the APAP to be used in runtime mode.
  • Patient flow-data is analyzed exactly the same way as done in the training phase to extract the values of the parameters used in the model i.e. the Feature Vector.
  • the vector is then presented to the network that will produce the output label (classification) which is used by the flow-control logic.
  • the signal should pass a device to remove the signal mean. Any kind of steep edge high pass filter can be employed, thus the ideal differentiator is used for simplicity.
  • the cepstrum coefficients have shown to well model the frequency content of the signal using only a few parameters (low order model). In addition, the dynamics of the cepstrum coefficients facilitate quantization of the parameters. Often the parameters are weighted to produce parameters with similar variances.
  • the cepstrum coefficients are derivatives of the so called A-polynomial calculated by standard Linear Predictive Coding (LPC).
  • the cepstrum coefficients used do not hold information about the signal energy, the cepstrum will be augmented with a parameter to account for the long term (say 10 seconds) energy variations. This parameter shall be insensitive to the absolute level of the flow signal and only reflect the relative fluctuations.
  • cepstrum coefficients c 1 ,K , c P are used as the P first coefficients in the Feature Vector.
  • PET Parameter of Energy Trend
  • the nodes are arranged in a square (2-dimensional) grid.
  • Feature Vector representing sample x k be denoted y k .
  • ANNEALING FUNCTION The task of the annealing function is to obtain an equilibrium at the end of the training. The principle is that large adjustments are allowed in the beginning of the training whereas only small (or zero) adjustments are allowed at the end. How the decrease incorporated is not critical. Linear, exponential, and even pulsating [4] decay schedules are proposed in the literature.
  • the iterative algorithm adjust all clusters after each input Feature Vector, y k , presented.
  • the direction of the adjustment is towards y k , and how much is determined partly by the annealing function, partly by the neighborhood function.
  • Various suitable functions are discussed in [3].
  • map nodes be arranged in an 8x8 square grid and numbered 0 to 63 from the top left to the low right corner.
  • a large database is recorded containing flow-measures from several patients during all phases of sleep. The recordings are performed at 20 Hz and stored on a memory disk. The database will contain normal sleep breathing, flow limitations, snoring, yawning, coughing, various apneic events, but also mask leakage and other artifacts.
  • the database is analyzed sample for sample.
  • the 20Hz flow-signal is first passed through an ideal differentiator.
  • a rectangular window of 180 samples is used to form basis for extracting 4 cepstrum coefficients ( c 1 ,K, c 4 ) and the PET parameter.
  • the Feature Vector is a 5-dimensional vector with values extracted every 50ms.
  • Samples are collected from the database in a random manner as long as the training proceed.
  • the number of iterations, T is determined by the size of the database, but as a rule of thumb, 10-30 iterations per sample may be an adequate number.
  • the neighborhood function will allow all clusters to be adjusted at all times (i.e. the size of neighborhood is not decreased in time), but will penalize clusters far away from the winner y l .
  • g t e - 2 ⁇ D kJ , ⁇ t
  • Regions with high response for normal breathing are labeled as normal regions; regions reacting for flow-limitations are labeled as flow-limitation area and so forth.
  • the map nodes are given a number 0, 2, 5, or 10 as labels to indicate the seriousness of the classification result.
  • the number is passed on. If for instance 0 reflects normal regions and 10 reflects apnea, the numbers can be integrated to form an overall breathing status classification. If the level is very high, rapid increases in pressure is allowed, low levels allow for a pressure decrease, and intermediate levels result in a slow increase of the pressure.
  • the LPC calculation can be decimated by a factor two or four. The number of samples within the analysis window must then be reduced so that the time span of the window is still about two breathing cycles. The resolution of the map response will not suffer from this.
  • the pressure control system will increase the pressure one step of 0.125 mbar if the ANN response is positive for 50 samples in one sequence.
  • the pressure will decrease with one step of 0.125 mbar if the ANN response is negative for 300 samples in one sequence.
  • the pressure will not be changed if the ANN response is changed during those sequences.
  • a sample of the flow signal is analyzed as described above (i.e. extracting the Feature Vector), and presented to the map, now stored in a memory bank in the APAP-unit. There is no need to calculate the exponent in the expression for map response, as the function is monotonic.
  • the PC Via the CPAP communication interface the PC was connected to the CPAP.
  • the PC software can read air flow values from the CPAP and set new pressure set points on the CPAP by the communication interface. The information was exchanged at a rate of about 20 Hz.
  • the PC program feeds the flow values into the artificial neural network (ANN).
  • the output from the ANN is entered into a pressure regulation algorithm (PRA).
  • PRA pressure regulation algorithm
  • the pressure regulation algorithm calculates a new pressure set point and activates the new value in the CPAP.
  • the output from the artificial neural network and the pressure setpoint is read by the PSG system. Evaluation.
  • a normal CPAP titration singleep disorder analysis
  • the CPAP pressure is adjusted during the night so as to put the patient in a state with no indications of sleep disorders. This pressure is the one used in the CPAP treatment.
  • the patient's need for various CPAP pressures can be seen with the PSG system breath-by-breath.
  • the required CPAP pressure varies depending on sleep stage, body position, etc..
  • the data from the auto CPAP test was evaluated in the PSG system in the same manner as for CPAP titration by a physician used to evaluate patients receiving CPAP treatment. Thereby the correlation between the detection of sleep disorder by the ANN and the analysis in the PSG system could be determined. The good correlation obtained indicated that the AFN reacted correctly.

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SE0003531 2000-10-02
SE0003531A SE0003531D0 (sv) 2000-10-02 2000-10-02 Auto CPAP
PCT/SE2001/002085 WO2002028281A1 (en) 2000-10-02 2001-09-28 Method and apparatus for cpap using a neural network

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CA2492528C (en) 2002-08-30 2014-03-18 University Of Florida Method and apparatus for predicting work of breathing
US8672858B2 (en) 2002-08-30 2014-03-18 University Of Florida Research Foundation, Inc. Method and apparatus for predicting work of breathing
US20050211249A1 (en) * 2002-11-19 2005-09-29 Mirko Wagner Ventilator method, ventilator and memory medium
US8020555B2 (en) * 2003-06-18 2011-09-20 New York University System and method for improved treatment of sleeping disorders using therapeutic positive airway pressure
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US20030000528A1 (en) 2003-01-02
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